DSAEK/DMEK and Cystoid Macular Edema - the Role for Topical NSAIDs (Nepafenac) (DMEC)
- Conditions
- Descemet Membrane Endothelial Keratoplasty (DMEK)Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
- Interventions
- Registration Number
- NCT05072262
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
The DMEC trial is a randomized clinical two-arm trial comparing inflammation and cystoid macular edema for the medication regimens postoperative topical NSAIDs and steroids to only postoperative topical steroids in patients undergoing corneal endothelial transplantations (DSAEK or DMEK).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Patients must be 18 years and older at the time of the signing of the informed consent. There is no upper age limit.
- Scheduled for DSAEK or DMEK
- Ability to cooperate fairly well during the examinations
- Willing to participate in the study and capable of giving informed consent, which includes compliance with the requirements and restrictions in the informed consent form (ICF) and in this protocol.
- Contraindications for use of any medication (as listed in the approved SPC, e.g. allergy, pregnancy, breastfeeding)
- Pregnancy or possible pregnancy during the study period
- Preoperative macular edema and/or ongoing treatment for macular edema
- Re-transplantation
- In-operated glaucoma shunt / valve (e.g. Ahmed glaucoma valve)
- Aphakic eyes (eyes without a biological or artificial intraocular lens)
- Loss of central vision (expected visual acuity potential after surgery below 0.1 Snellen)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study group (NSAIDs and dexamethasone) Dexamethasone Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery. Control (dexamethasone only) Dexamethasone Ophthalmic Topical dexamethasone 1 mg/ml (Spersadex) started the day after surgery Study group (NSAIDs and dexamethasone) Nepafenac Ophthalmic Topical nepafenac (Nevanac) 3 mg/ml and dexamethasone 1 mg/ml (Spersadex) started the day after surgery.
- Primary Outcome Measures
Name Time Method Central macular thickness after 4 weeks 4 weeks after surgery Measure central macular thickness (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) after 4 weeks 4 weeks after surgery Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
- Secondary Outcome Measures
Name Time Method Intraocular inflammation Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery Measured by laser flare meter
Intraocular pressure Preoperatively, and 1 day, 1 week, 4 weeks, 2 months and 2 years after surgery Measured by tonometry
Visual outcome Preoperatively, and 1 week, 4 weeks, 2 months and 2 years after surgery Measure uncorrected and corrected distance visual acuity using visual acuity chart
Corneal endothelial status 1 week, 4 weeks, 2 months and 2 years after surgery Measure corneal endothelial cell density using microscopy instrument
Patient reported outcome measure (PROM) 1 week, 4 weeks and 2 months after surgery COMToL questionnaire for ocular medication
Central macular thickness (CMT) Preoperatively, and 1 week, 2 months, and 2 years after surgery Measure CMT (in um) on optical coherence tomography (OCT)
Cystoid macular edema (CME) Preoperatively, and 1 week, 2 months, and 2 years after surgery Determine if the patient has CME based on evaluation of macular cysts on optical coherence tomography (OCT)
Trial Locations
- Locations (1)
Department of Ophthalmology, Oslo University Hospital
🇳🇴Oslo, Norway